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Terminated

Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955

FDA Recall Z-2601-2018 · Posted None

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeGAM
Date Initiated2018-06-15
Date Terminated2019-05-08
Product Quantity972 units

Reason for Recall

Potential proplylene glycol contamination

Firm Action

All U.S. consignees were notified via Federal Express or certified mail on June 15, 2018, and the letter informs customers of the potential that the suture was contaminated with propylene glycol during the manufacturing process and the actions they should take. Customers are advised to discontinue use of the product and return all inventory of the affected lot to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.

Root Cause

Nonconforming Material/Component

Distribution Pattern

CA, NY & TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981935POLYSORB SUTUREUnited States Surgical, A Division of Tyco Healthc · 1998-06-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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